Adverum Biotechnologies presents 26-week interim analysis of Ixo-vec trial

Adverum Biotechnologies announced results from the landmark 26-week interim analysis of the ongoing LUNA Phase 2 trial of Ixo-vec in patients with wet age-related macular degeneration, or AMD. These data are being presented by Charles Wykoff at the 42nd annual meeting of the American Society of Retinal Specialists in Stockholm, Sweden. Both the 6E10 and 2E11 doses demonstrated maintenance of visual and anatomic outcomes. Notably, both doses resulted in a potentially best-in-class percentage of patients remaining free of anti-vascular endothelial growth factor, or VEGF, injections and reduction in annualized anti-VEGF injections and, with data trending similar to or better than the OPTIC study. Ixo-vec demonstrated a significant proportion of patients injection free at both doses at week 26. 6E10: 76% of patients injection free; 2E11: 83% of patients injection free; Ixo-vec demonstrated a significant reduction in mean annualized anti-VEGF injections at week 26. 6E10: 90% reduction in mean annualized anti-VEGF injections and 2E11: 95% reduction in mean annualized anti-VEGF injections. Visual, or BCVA, and Anatomic, or CST, Outcomes: Visual acuity was maintained at both dose levels – least squares mean BCVA change from baseline at week 26: 6E10: -1.1, 2E11: -2.2. Fluid control was maintained at both dose levels – least squares mean CST change from baseline at week 26: 6E10: -12.6, 2E11: -12.0. Sub-group with CST greater than 300 microm at baseline: -30.2. Ixo-vec was well tolerated at both doses. No Ixo-vec-related serious adverse events. No episcleritis, vasculitis, retinitis, choroiditis, vascular occlusion, or hypotony. All Ixo-vec-related adverse events were either mild or moderate. The most common Ixo-vec-related adverse events were dose-dependent anterior inflammation responsive to local corticosteroids and anterior pigmentary changes with no impact on vision. Improved inflammatory profile observed with enhanced corticosteroid prophylaxis in LUNA as compared to OPTIC. Oral prednisone did not demonstrate incremental benefit. Ozurdex without difluprednate did not provide adequate prophylaxis. All of the patients receiving the difluprednate-alone prophylactic regimen have completed their prophylaxis, enabling evaluation of this regimen at the interim analysis. Inflammation was dose-dependent and, when present, was responsive to local corticosteroids. 6E10: 100% of patients have no or minimal inflammation at the 26-week timepoint. No participants at 6E10 received corticosteroids for treatment of inflammation beyond the scheduled prophylaxis. 2E11: 90% of patients have no or minimal inflammation at the 26-week timepoint. Topical difluprednate effectively managed inflammation when present. For the LUNA interim analysis, a pre-specified Patient Preference Survey was performed at week 26 to understand patient preferences after receiving Ixo-vec, including whether patients preferred Ixo-vec, along with the accompanying prophylactic regimen, over prior treatments and whether patients would elect to receive Ixo-vec in the fellow eye. At the 26-week landmark analysis, 88% of the entire LUNA patient population responded that they would prefer Ixo-vec therapy over the prior treatment(s) they received, and 93% responded that they would want to receive Ixo-vec in the fellow-eye if they had bilateral disease. Of the patients receiving 6E10 and the difluprednate-alone prophylactic regimen: 100% responded that they would prefer Ixo-vec therapy over the prior treatments received; and, 100% responded that they would want to receive Ixo-vec in the fellow eye.